Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile Dysfunction

Phase 3CompletedNCT00658177

Bayer463 enrolled

Overview

Study to investigate the efficacy and safety of Vardenafil

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

463

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

20mg to be taken 1 h prior to sexual intercourse

PlaceboDRUG

Matching placebo

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, * History of unresponsiveness to sildenafil * Stable sexual relationship for \> 6 month. Exclusion Criteria: * Primary hypoactive sexual desire * History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month * Nitrate therapy * Other exclusion criteria apply according to the US Product Information

Outcomes

Primary Outcomes

Sexual Encounter Profile Question 2

Time frame: 12 weeks

Secondary Outcomes

Sexual Encounter Profile Question 3

Time frame: 12 weeks

Internation Index of Erectile Function-Erectile Function domain

Time frame: 12 weeks

Safety and tolerability

Time frame: 12 weeks

Data from ClinicalTrials.gov

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